Stryker Leibinger GmbH & Co.KG
Active in EUDAMEDGermanyfrom SRN EUDAMED SRN DE-MF-000005522
- Devices
- 12
- Registrations
- EUDAMED
At a glance
EU certificates
3 of 4 in force. 1 certificate has expired.
Market reach
- European Union
- EUDAMED actor, 4 certificates
What Stryker Leibinger GmbH & Co.KG makes
Stryker Leibinger GmbH & Co.KG manufactures the VariSpeed, a device designed for orthopedic applications, specifically as a modular intramedullary nail system for the femur. This product is intended for internal fixation of femoral shaft fractures, providing stability during the healing process.
The VariSpeed is classified as a Class I medical device under EU regulations and is registered in the EUDAMED database. The company is based in Germany and adheres to relevant regulatory requirements for its listed devices.
Catalogue
Search and filter all 12 devicesCompany details
- EUDAMED SRN
- DE-MF-000005522
- EU VAT number
- DE188912879
- EUDAMED status
- Active
- EUDAMED registered name
- Stryker Leibinger GmbH & Co.KG
- EUDAMED abbreviated name
- Stryker Leibinger
- Registered address
- 41, Bötzinger Straße, 79111, Freiburg, Germany
- Website
- www.stryker.com
- [email protected]
- PRRC contact
- Pernel van den Hurk
EUDAMED certificates
4 certificates3 valid, 1 expiredMDR 4next expiry 21 Dec 2030
TÜV Rheinland LGA Products GmbH 0197 4 certificates
- IZ 1762136-2 Active
Technical documentation EU MDR
- Issued
- 18 Sep 2026
- Expires
- 3 Oct 2031
- Valid from
- 4 Oct 2026
- IZ 1762136-3 Active
Technical documentation EU MDR
- Issued
- 18 Sep 2026
- Expires
- 3 Oct 2031
- Valid from
- 4 Oct 2026
- HZ 1762136-1 Active
Quality management system EU MDR
- Issued
- 18 Dec 2025
- Expires
- 21 Dec 2030
- Valid from
- 22 Dec 2025
- HZ 1762136-1 Expired
Quality management system EU MDR
- Issued
- 16 Dec 2025
- Expires
- 21 Dec 2025
- Reason
- Add device or group
Frequently asked questions
How many devices does Stryker Leibinger GmbH & Co.KG have in the registry?
The registry currently lists 12 devices for Stryker Leibinger GmbH & Co.KG. Devices recorded under merged duplicate company entries are counted once.
Which registries list Stryker Leibinger GmbH & Co.KG's devices?
Among its 12 most recently registered devices, Stryker Leibinger GmbH & Co.KG has devices listed in EUDAMED (11 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Stryker Leibinger GmbH & Co.KG's devices fall under?
Among its 12 most recently registered devices, the classes recorded for Stryker Leibinger GmbH & Co.KG's devices are Class I, Class IIb and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Stryker Leibinger GmbH & Co.KG?
EUDAMED lists 4 certificates for Stryker Leibinger GmbH & Co.KG (technical documentation; quality management system) under MDR. The most recent was issued on 18 Sep 2026.
What are the newest devices from Stryker Leibinger GmbH & Co.KG in the registry?
The most recently registered devices listed for Stryker Leibinger GmbH & Co.KG include RibPlate System, Universal - Upperface module 1.2/Universal - Midface module 1.7 Storages, MMF AXS and Universal Mandible AXS.